Status:
ACTIVE_NOT_RECRUITING
TDM Guided Early Optimization of ADAL in Crohn's Disease
Lead Sponsor:
waqqas.afif
Collaborating Sponsors:
AbbVie
Conditions:
Crohn Disease
Drug Monitoring
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To investigate the influence of early therapeutic drug monitoring and dose optimization on disease outcome in Crohn's patients treated with Adalimumab.
Detailed Description
This is an investigator initiated randomized open label study. This study is designed to compare whether increasing the dose of adalimumab based on the level the drug in the blood to a target level ea...
Eligibility Criteria
Inclusion
- Age 18 or older.
- Crohn's disease diagnosed based on standard objective methodology (clinical, biochemical, endoscopic, histological and radiological correlation).
- Active disease based on Harvey Bradshaw Index (HBI \>5) and elevated C-reactive protein (CRP) (\>normal reference range for local laboratory) OR fecal calprotectin (FCP) (\>250 µg/g)
- Due to commence treatment with ADAL.
Exclusion
- Severe co-existing cardiopulmonary, hepatic, renal, neurologic, or rheumatologic disease.
- History of active HIV, hepatitis B or C infection,
- Patients with ileostomy/colostomy, ileal-pouch anal anastomosis or severe perianal fistulising disease.
- Pregnancy
- Prior exposure to ADAL
Key Trial Info
Start Date :
January 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03261102
Start Date
January 17 2017
End Date
June 1 2025
Last Update
May 25 2025
Active Locations (6)
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1
University of Calgary Medical Center (UCMC)
Calgary, Alberta, Canada, T2N 4Z6
2
The University of British Columbia
Vancouver, British Columbia, Canada, V6Z 1Y6
3
London Health Sciences Centre (LHSC) University Hospital
London, Ontario, Canada, N6A 5A5
4
The Ottawa Hospital, IBD Centre of Excellence
Ottawa, Ontario, Canada, K1H 8L6